Apparatus and method for treating multiple tumors in patients with metastatic disease by electric fields

ABSTRACT

An insulated electrode system for delivering a plurality of tumor treating electromagnetic fields including an array of electrode elements for proximate location on a body of a patient. Each electrode element of the array having an insulation layer. Each electrode element being independently electrically accessible and configured to be assigned to emanate an electromagnetic field relative to at least one other of the electrode elements.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a divisional application based upon U.S. non-provisional patentapplication Ser. No. 14/795,597, now issued as U.S. Pat. No. 9,833,617,entitled “APPARATUS AND METHOD FOR TREATING MULTIPLE TUMORS IN PATIENTSWITH METASTATIC DISEASE BY ELECTRIC FIELDS”, filed Jul. 9, 2015, whichis incorporated herein by reference. U.S. non-provisional patentapplication Ser. No. 14/795,597 is based upon U.S. provisional patentapplication Ser. No. 62/028,996, entitled “APPARATUS AND METHOD FORTREATING MULTIPLE TUMORS IN PATIENTS WITH ADVANCED METASTATIC DISEASE BYELECTRIC FIELDS”, filed Jul. 25, 2014.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to tumor and cancer cell treatment andmore specifically to treatments involving the application ofelectromagnetic fields.

2. Description of the Related Art

Alternating Electric Fields, also referred to as Tumor Treating Fields(TTF's), can be employed as a type of cancer treatment therapy by usinglow-intensity electromagnetic fields. These low-intensity fields rapidlychange direction, thousands of times per second. Since the TTF's areelectric fields, they do not cause muscle twitching or severe adverseside effects on other electrically activated tissues. The growth rate ofmetastatic diseases is typically greater than the growth rate of normal,healthy cells. Alternating Electric Fields therapy takes advantage ofthis high growth-rate characteristic. TTF's act to disrupt a cancercell's mitotic process and cytokinesis by manipulating the cell'spolarizable intracellular constituents, namely tublins that form mitoticspindles that pull the genetic material in the nucleus into tow sistercells. TTF's interrupt mitotic spindle microtubule assembly therebypreventing cell division. The metastatic disease cells treated usingTTF's will go into programmed cell death usually within 4 to 5 hours.The result is a significant reduction in tumor size and potential forfull elimination of solid tumors. TTF's are tuned to treat specificcancer cells and thereby do not damage normal cells. TTF therapy can beused as a sole treatment method, or it can be combined with conventionaldrug delivery mechanisms.

TTF's are applied to patients using insulated electrodes adhered to theskin by a variety of methods including the use of medical adhesives,articles of clothing, etc. There are multiple configurations ofinsulated electrodes, but all have an insulated material with a highdielectric constant on one side and a thin metal coating on the other,usually silver. Insulated electrodes used to generate TTF's always comein pairs with both sides being similar, but not necessarily the same.

Referring now to FIG. 1, there is shown a typical insulated electrodearray 10 used in the administration of TTF's. The insulated electrodearray 10 includes a pair of arrays, 10A and 10B, which are made fromsmaller insulated electrode sub-elements 12. Because the insulatedelectrode 10 archetypically works in pairs, there is generally aSub-array A and Sub-array B, respectively 10A and 10B. Each smallerinsulated electrode 12 has an insulating material 14, typically aceramic that is adhered to the patient. The leads 16 interconnect thesmaller insulated electrodes 12 to a main lead line 18, which links to agenerator (not shown).

Confusion arises in the prior art when the term insulated electrode isinterchanged with the term “Isolect” or just “Electrode”. These termsare sometimes used to describe “elements of an array” or entire sets ofarrays. It is often not disclosed in the prior art exactly what is meantby any of the above terms. It should be appreciated by persons skilledin the art that insulated electrodes or terms used in exchange forinsulated electrodes are generally references to either fixed arrays ofsmaller dedicated insulated electrode sub-elements 12 as shown in FIG. 1or to large solid insulated electrodes 20 as shown in FIG. 2.

There are many reasons small insulated electrodes 12 used individuallywill not work when producing TTF's, a non-exhaustive list includes:

-   -   1. Small elements used individually do not draw enough energy to        form an electric field that will go through the human torso. For        example, 4 amps over an area of approximately 1 square foot may        be required to create an effective TT field strong enough to        treat cancer tumors in the lungs. Small elements used        individually cannot draw the required energy. In other words        there is a minimum current density (amps/area) and a minimum        area required to be effective. Single small insulated electrodes        cannot meet these requirements. Placing small electrodes into an        array close together and energizing them at the same time so        that they act as one insulated electrode solves this problem.    -   2. If a small element was designed to carry enough energy to go        through the lungs (e.g., 4 amps/sq. ft.), the resulting        concentration of that much energy in a small area generally        causes tingling on the patient's skin making treatment regimen        unbearable.    -   3. If small elements were used individually to produce TTF's,        their physical size and shape would create inefficiencies when        treating massive areas like cancer spread throughout the pleura        membranes. The pleurae, inside the thoracic cavity, generally        extend from just below the clavicle area to the lower ribs.        Using small individual insulated electrodes would increase the        likelihood of gaps in field coverage, which in turn could allow        cancer cells to persist.

While large insolated electrodes 20, shown in FIG. 2, produce adequatefields, they have many disadvantages such as the inability to expandwhen a patient's skin stretches during bending or sitting. Largeinsulated electrodes 20 also tend to draw more energy at their center,causing tingling similar to that of over-powered smaller insulatedelectrodes. In contrast, insulated electrodes comprising arrays ofsmaller insulated electrode sub-elements can deliver energy in a morediffused manner and can adapt to the human body more easily.

Generally, in prior art references processes to choose insulatedelectrodes in groups, is referring to choosing a smaller group ofelements from a larger group. What is typically shown in drawings and isdone in practice, is that choosing a smaller number of electrodes from alarger group is for the purpose of wiring the smaller group together ina fixed, dedicated array. In the prior art processes of targeting TTF'sfrom multiple sites to vector a treatment area, it is referring totargeting multiple fixed dedicated arrays or multiple large electrodes.When the prior art references mention sweeping through electrodes totarget tumors from different angles, it is referring to energizingdifferent fixed dedicated arrays in a sequential manner. It is generallyunderstood that the prior art refers to fixed dedicated arrays or largeelectrodes when it discusses manipulating TTF's. Further, the prior artreferences disclose that insulated electrode sub-elements are dedicatedfor use in a single array and single power sub-array A or B. This is dueto how array elements are wired (see FIG. 1). This creates seriousdrawbacks when treating patients with metastatic disease.

Referring collectively now to FIGS. 3 and 4, there is shown a typicalprior art TTF treatment configuration on a patient with metastaticbreast cancer. The metastatic cancer, illustrated as black spots 30, isshown to have spread throughout the pleura around the left lung (FIG.3). These cancer cells are literally free floating in fluid within thepleura cavity, and are forming many new small tumors. Additionally,there are also small tumors located on the liver.

FIG. 4 shows an insulated electrode array 40 for the left lung and aninsulated electrode array 42 for the liver, each including a respectivepair, sub-array A and B. The left lung insulated electrode array 40 willfire its sub-array A array 40A with its sub-array B array 40B, and theliver insulated electrode 42 will fire its respective sub-array A array42A with 42B. Typically, a cross firing of arrays will be programmed totarget the cancer from different angles. In the case of cross firing,the front side A array 42A of the liver insulated electrode array 42will fire with the back sub-array B array 40B of the left lung insulatedelectrode array 40A, and the front sub-array A array 40A of the lunginsulated electrode array 40 will fire with the liver back sub-array Barray 42B. However, in the above scenario cross firing may not bepossible because of the significant difference in size between the lungand liver insulated electrodes, 40A and 40B. Of course, many othercross-firing combinations can be programmed. The significant limitationof the prior art is that each sub-element 12 of either array 40 or 42 issolely dedicated to its respective home insulated electrode array and toits home sub-array A or B array. In other words, a particularsub-element 12 is solely linked and devoted to its particular insulatedelectrode array and side and cannot be used except in the function ofits home array.

FIG. 5 portrays how cancer cells 30 in the pleura and the liver areactually beginning to shrink, but new cancer cells 30 have appeared inthe upper peritoneal cavity above the navel in between the left lung 40and liver 42 insulated electrode arrays. Likewise, new cancer cells 30have appeared near the lower peritoneal cavity.

As shown in FIG. 6, to combat the new cancerous growth in between theinsulated electrodes, 40 and 42, there needs to be a new insulatedelectrode array 44 centering the tumors in the upper peritoneal cavity,region 45. This is not possible because it would require placingelements 12 on top of elements 12, as array 44 would overlap with thearrays 40 and 42, which would deny skin contact needed for proper fieldformation. This limitation in the prior art leads to treatmentcompromises, putting the patient at risk by failing to treat new tumorsas the primary disease. Coplanar fields between the liver and lung arenot desirable here because of the significant size difference betweenthe two insulated electrodes, 40 and 42.

Referring now to FIG. 7, there is shown an illustration of a TT fieldwhere region 46A is the effective TTF area and region 46B is theineffective TTF area. This portrays the importance of being able totarget each area of tumor growth as a primary concern. TTF's vary inintensity throughout their shape, which can cause significant areas of afield to be below the effective strength. As shown by region 46B, it ispossible for tumors to be covered by a field without actually having anybeneficial effect because the intensity is not sufficient enough toprevent cell division. In addition, the extreme variance of tissue typesand even air pockets within the body can create pockets where fieldformation is not possible if treatment is attempted from limiteddirections.

As shown in FIG. 8, continuing with the metastatic breast cancer exampleshown in FIGS. 4-6, a new insulated electrode array 48 is added toaddress the new tumor growth in the lower peritoneal cavity. Theinsulated electrode array 48 is designed to develop a co-planner field(half Moon), horizontally from left to right. In order to form aco-planner field, the array 48 pairs 48A, representing sub-array A, and48B, representing sub-array B, together in the same front plane of thepatient. In TTF best practices it is known that targeting a tumor fromdifferent angles increases the effectiveness of tumor reduction.However, prior art treatment with dedicated array elements iscompromising the treatment of the patient in this example.

Prior art treatment with dedicated array elements does not have enoughversatility to adequately address multiple disease locations. Creating asecond co-planner field using the liver insulated electrode array 42 andthe lower peritoneal cavity insulated electrode array 48 to create avertical field cannot be done on the right side because both arrays arededicated to the A sub-array. Further, multidirectional pairing is notpossible because three of the four sub-arrays (40A, 42A and 48A) locatedon the front side of the patient are solely dedicated to sub-array A. Aand B sides are required to establish coupling and field formation. Inaddition the differing sizes of the liver insulated electrode array 42and the lower peritoneal cavity insulated electrode array 48 are toodissimilar to form the desired field. Undesired field concentrationwould occur (twenty-four elements 12 in array 42 to fifteen elements 12in array 48). Also, the distance to the back liver and lung arrays aretoo far from the front peritoneal cavity to create an effective field.

In this example the prior art leaves the cancer in the upper peritonealcavity untreated and the cancer in the lower peritoneal cavity undertreated. Such short comings in the prior art can lead to a lack of tumorresolution, unnecessary pain and suffering in the patient, or evendeath. The prior art is inefficient in that new custom dedicated arraysneed to be constantly designed and physically built to address changesin patients with metastatic disease. TTF treatment in the prior artfails the patient, as shown in FIGS. 4-6 and 8, and the patient willlikely return to heavy chemotherapy, which can lead to days if not weeksof hospitalization and eventual death. At the time of this writing theredoes not exist a chemotherapy that does not eventually fail stage 4patients who become reoccurring and non-responsive. As of 2014 the fiveyear survival rate for stage 4 breast cancer, for example, is only 22%according to the American Cancer Society. A new TTF system needs to beapplied in order to treat metastatic disease.

In general TTF treatment using prior art array shapes are determinedbefore they are built. Then, for efficiency reasons, these minimalizedarray sizes are physically constructed. This however is inefficient whentreating metastatic disease because the treatment areas continuallychange as the cancer spreads. Requiring frequent reconfiguring ofarrays. What is needed in the art is the ability to quickly change theconfigurations of arrays.

When a patient is wearing TTF arrays it is important to ensure adequatewarning if any overheating of the elements occurs. The prior artapproach generally addresses this concern with temperature sensors thatshut off the TTF device if overheating occurs. What is of equal concernis current leakage to the skin. Some patients, desiring the resolutionof their disease, may have a tendency to endure warm spots that areactually current leaks. These leaks can cause blistering if notaddressed quickly. The electric current levels per element are so low onTTF devices that current leakage can feel much like a warm heating pad.Of course adequately constructing elements to prevent leakage is thefirst line of defense for this issue. However, TTF arrays are expensiveand in some cases can be worn for months at a time to save money. Theelectrode elements may experience various unknown types of stress duringdaily activity. It is conceivable that an insulated electrode array maybe dropped, etc. The prior art systems lack a current monitoring system.

Array migration and overall warmth of the insulated electrodes can be anissue during TTF treatment. When working with patients with metastaticdisease it is more likely that full body arrays will be worn toadminister TTFs. When full body TTF arrays are worn during sleep andduring other long periods of time it is a challenge to keep them frommigrating to less optimal positions. For example, tossing and turningduring sleep can exasperate this problem. In addition, warmth from theelements can cause sweating in some cases, which further enablesslipping of the arrays as body movement occurs. The prior art has manymethods of securing array elements to the skin including various shirts,medical adhesives, etc. These methods are not as successful when used onfull-body arrays.

Metastatic disease can literally have dozens of tumor groupingsthroughout a patient's body. For example, metastatic breast cancer canspread to the lungs, liver, peritoneal cavity, and pancreas all at thesame time. Large organs such as the liver can have tumor groupings veryfar apart. Metastatic disease in the pleura around the lungs and in theperitoneal cavity can pepper large areas of the abdomen with growingcancer cells. Using electric fields on metastatic disease has broughtabout the need for significant improvements in the application andgeneration of effective tumor treating fields (TTFs).

What is needed in the art, is a TTF system that enables the dynamicreassignment of array elements to thereby define any array needed and toapply the field from either sub-array A or B.

What is needed in the art is a modular system for adding and removingarray elements.

What is needed in the art is a current monitoring sensor that sends ashut off signal to the control device if fluctuations in current, whichmay be caused by current leakage to the skin or the detachment of theelectrode, is detected.

What is needed in the art is a method of adhering array elements to amaterial while also reducing the temperature of the array elements.

SUMMARY OF THE INVENTION

The present invention provides an improved cancer and tumor treatmentregime.

The invention in one form is directed to an insulated electrode systemfor delivering a plurality of tumor treating electromagnetic fieldsincluding an array of electrode elements for proximate location on abody of a patient. Each electrode element having an insulation layer.Each electrode element being independently electrically accessible andconfigured to be dynamically assigned to emanate an electromagneticfield relative to at least one other of said electrode elements.

The invention in another form is directed to an insulated electrodearray for delivering a plurality of tumor treating electromagneticfields including an array of a plurality of electrode elements eachhaving an insulation layer. Each electrode element being independentlyprogrammable and dynamically assignable to a first sub-array then to asecond sub-array. A modular system has a plurality of end-to-end elementmodules incorporating the electrode elements. A control device isconfigured to dynamically program a frequency range, a firingconfiguration and a firing sequence for each of the electrode elements.A field generator is configured to generate an electrical signal in thefrequency range. There is a flex circuit in electrical communicationwith both the field generator and the modular system.

The invention in yet another form is directed to a method of deliveringtumor treating electric fields to a patient. The method includes thesteps of: arranging an insulated electrode element array on the patient;programming a frequency range, a firing configuration and a firingsequence for each electrode element; assigning at least some of theelectrode elements to a first sub-array and at least one of theelectrode elements to a second sub-array; and dynamically assigning atleast one of the electrode elements of the first sub-array to the secondsub-array, and at least one of the electrode elements of the secondsub-array to the first sub-array.

An advantage of the present invention is that each array element in theinventive device can be redirected to either power sub-array A or B andto any array combination desired and to any frequency desired.

Another advantage of the present invention is that it allows for auniversal system that can adapt to body composition and the spread ofmetastatic disease.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of this invention,and the manner of attaining them, will become more apparent and theinvention will be better understood by reference to the followingdescription of embodiments of the invention taken in conjunction withthe accompanying drawings, wherein:

FIG. 1 is an illustration of a prior art insulated electrode array;

FIG. 2 illustrates large solid insulated electrodes used in the priorart;

FIG. 3 illustrates tumor locations in a patient;

FIG. 4 illustrates the placement of prior art electrode arrays on apatient;

FIG. 5 portrays how cancer cells in the pleura and the liver arebeginning to shrink, but new cancer cells having appeared in the upperperitoneal cavity above the navel, in between the left lung and liver,and in the lower peritoneal cavity;

FIG. 6 illustrates the need for a new insulated electrode array centeredon the tumors in the upper peritoneal cavity, and the difficulty inadapting the prior art;

FIG. 7 illustrates a TT field where there is an effective region and anineffective region of treatment in the prior art systems;

FIG. 8 illustrates an insulated electrode array that develops aco-planner field, half-Moon field, horizontally from left to right;

FIG. 9 is a diagram illustrating an embodiment of the present inventionin the form of an insulated electrode array whereby each sub-element isprogrammable to energize in any array configuration and to the Asub-array or the B sub-array;

FIG. 10 is a diagram that illustrates a second embodiment of the presentinvention wherein the electrode elements further include a communicationinterface;

FIG. 11 illustrates a third embodiment of the present invention in whicheach electrode element includes a flexible wireless antenna;

FIG. 12 is a diagram illustrating a fourth embodiment in which theintegrated circuit and relays are in the same case as the fieldgenerator;

FIG. 13 illustrates a fifth embodiment according to the presentinvention in which each electrode element includes a microprocessor;

FIG. 14 is a diagram that illustrates a sixth embodiment of the presentinvention wherein each electrode element includes a single relay;

FIG. 15 is a diagram that illustrates how each embodiment may include anautomatic current sensor as an extra safety precaution;

FIG. 16 is a diagram that illustrates a simplified electrode arrayelement;

FIG. 17 is a diagram that illustrates the application of the presentinvention on the example patient with metastatic breast cancer that wasused in FIGS. 3-8;

FIG. 18 illustrates the first step in a TTF 6-step treatment sequenceusing dynamic reassignment of array elements;

FIG. 19 illustrates the second step in the TTF 6-step treatment sequenceusing dynamic reassignment of array elements;

FIG. 20 illustrates the third step in the TTF 6-step treatment sequenceusing dynamic reassignment of array elements;

FIG. 21 illustrates the fourth step in the TTF 6-step treatment sequenceusing dynamic reassignment of array elements;

FIG. 22 illustrates the fifth step in the TTF 6-step treatment sequenceusing dynamic reassignment of array elements;

FIG. 23 illustrates the sixth step in the TTF 6-step treatment sequenceusing dynamic reassignment of array elements;

FIG. 24 is a diagram that illustrates another embodiment according tothe present invention in the form of a modular system;

FIG. 25 is a diagram that illustrates an eighth embodiment according tothe present invention in which a current monitoring sensor can beincluded on each electrode element;

FIG. 26 is a diagram illustrating a ninth embodiment according to thepresent invention that prevents array migration and minimizes overallwarmth;

FIG. 27 is a diagram that illustrates a tenth embodiment according tothe present invention incorporating large single electrode elements;

FIG. 28 is a diagram that illustrates an insulated electrode arrayaccording to the present invention used to accommodate an irregular bodyshape of a patient; and

FIG. 29 is a flow chart that illustrates the unique and enhancedcapabilities of TTF treatment using dynamic reassignment according tothe present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate embodiments of the invention and such exemplifications arenot to be construed as limiting the scope of the invention in anymanner.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIG. 9, there is shown an embodiment of the presentinvention in the form of an insulated electrode array 50. The insulatedelectrode array 50, in the form of an array pair having a sub-array 50A(which for the purposes of illustration is on the front) and a sub-array50B (illustrated on the back), includes a plurality of insulatedelectrode elements 52 interconnected by a multilayer flex circuit 54 toa control device 56 and a field generator 58. The multilayer flexcircuit 54 in this particular embodiment contains a lead A, a lead B, acommunication wire, and a ground wire (not shown for the sake ofclarity). However, the multilayer flex circuit 54 is not limited to thisconfiguration. FIG. 9 illustrates an insulated electrode array 50 wherethe control device 56 is programmed to send signals to the fieldgenerator 58 (including the frequency range) to be sent individually ina dynamic fashion to each of the array elements 52, as well as which ofthe array elements 52 are to be used in a particular configuration andsequence. One can appreciate that there are many ways to achieve dynamicreassignment of array elements when administering TTF's.

Each insulated electrode element 52 includes an integrated circuit 60attached to two activatable switches, which may be in the form of tworelays 62A (which is referred to herein as phase A) and 62B (which isreferred to herein as phase B). A feed through 64 is used tointerconnect the relays, 62A and 62B. Each integrated circuit 60 has aunique address. Further, each element 52 has two small low-light LED's;a first LED 66A configured to light up when phase A is being used and asecond LED 66B configured to light up when phase B is being used. Thedesired configuration of the array elements 52 and the firing sequenceare entered into the control device 56. The control device 56 mayinclude a computer interface (not shown). The control device 56 directseach insulated electrode element 52 to turn on or off and directs it tobe used for phase A or phase B of a given array. Each insulatedelectrode element 52 can be dynamically reassigned.

Now, additionally referring to FIG. 10, there is shown a secondembodiment of the present invention, an insulated electrode array 70formed by sub-arrays 70A (front) and 70B (back). In this embodiment thecommunication wire is not used or is removed from the multilayer flexcircuit 54 and each element 52 now includes a communication interface 72with the integrated circuit 60. A signal is sent down the A and B leadwires of the multilayer flex circuit 54 at a different frequency thanthe TTF to direct the desired commands to each element 52. Also, thefield generator 58 includes a command generator 74 for signaling theintegrated circuit 60.

Referring now to FIG. 11, there is shown a third embodiment of thepresent invention, an insulated electrode array 80 being formed bysub-arrays 80A (front) and 80B (back). In this embodiment, eachindividual element 52 includes a flexible wireless antenna 82 and awireless communication interface 84 that enables the receiving ofcommands from a wireless signal generator 86 within the TTF fieldgenerator 58.

Referring now to FIG. 12, there is shown a fourth embodiment in the formof an insulated electrode array 90, a front sub-array 90A and a backsub-array 90B. In this embodiment, each integrated circuit 60 and relaypair 62A, 62B corresponding to a thin array element 92 is positioned inthe same case 94 as the TTF generator 96. Thereby, the TTF generator 96has a built-in dynamic reassignment. All the wires from the fieldgenerator 96 are run through the multilayer flex circuit 54, or anyother suitable carrier, to each thin array element 92. Each thin arrayelement 92 has its own power and communication wires (not shown). Thinarray elements 92, as a result of not housing an integrated circuit 60and relays 62A, 62B are much thinner than electrode elements 52. Thus,thin array elements 92 accommodate some patients who require less of aprotrusion next to their skin. For example, thin array elements 92 causeless discomfort to obese individuals when they are sleeping.

Referring now to FIG. 13, there is shown a fifth embodiment in the formof an insulated electrode array 100, pairing a front sub-array 100A anda back sub-array 100B. In this particular embodiment, the integratedcircuit 60 is replaced by a small microprocessor 102. This embodimentallows pre-programmed firing states (array configurations and firingsequences) to be preloaded on each array element 52. This allows forbroadcast communication to all array elements 52 simultaneously forfaster switching. Each firing state is given a single or double digitID. This firing ID code (or state ID) is appropriately broadcast to allarray elements 52 at once. One message is sent to accomplish the firingstate verses potentially hundreds using an integrated circuit alone.

Referring now to FIG. 14, there is shown a sixth embodiment, aninsulated electrode array 110, sub-arrays 110A (front) and 110B (back).This embodiment uses a single relay 112 per array element 52. Amicroprocessor 102, as shown in FIG. 14, or an integrated circuit 60could be used to manipulate the relay 112. A feed through 114 is coupledto the relay 112 in order to supply power to each array element 52.Using relay 112 has the effect of keeping the dynamic reassignment foran array configuration, but it dedicates array elements 52 to either theA or B phase (any one of which can be on the front or back). This isuseful when there is no likely need for coplanar fields.

Now, additionally referring to FIG. 15, a master current sensor 116 canbe used in any of the aforementioned embodiments. The master currentsensor 116 is positioned at the head of a given insulated electrodearray or within a given electric field generator. In other words, themaster current sensor 116 is positioned upstream before the electrodearray elements 52. The master current sensor 116 monitors for unusualpower fluctuations that may indicate that a compromised array element 52has allowed current to flow directly to a patients skin. In such anoccurrence the master current sensor 116 would automatically shut offthe entire system. Current flow directly to a body would only be at verysmall amperages (in most configurations a maximum of 0.13 amps).However, as this would still be undesirable it would justify anautomatic shut off.

It should be appreciated that the above methods of achieving dynamicreassignment of array elements 52 when administering TTF's can beaccomplished without multilayer flex circuits 54 by instead usingregular wiring and small hard printed circuit boards (not shown) foreach array element 52. Future embodiments may be achieved throughprinting switching circuitry directly into flex material. Each of theabove embodiments can use intermittent messaging to avoid possibleinterference between the communication with array elements 52 and theactual energizing of each array element 52. All configurations can beaccomplished with elements 52 of varying shapes and sizes. The number ofelements 52 in a given array can be as little as 2 up to 500 or more. Inaddition, as shown in FIG. 16, another simplified embodiment of thepresent invention can utilize specially designed array elements 120 thatseparate the conductive area 122 that is on the insulation, which isgenerally a silver coating, into A and B dedicated sections, 122A and122B respectively. The zone separator 124 helps to visualize thisdistinction. Also, a lead A solder point 126A and a lead B solder point126B respectively portray the dedication to 122A, 122B sections. Thisembodiment yields fewer array options, but it does allow multiple usesacross sides of the same elements 120.

FIG. 17 also shows the patient with metastatic breast cancer that wasused in the previous example (FIGS. 3-8). Each small insulated electrodeelement 52 is ready for dynamic reassignment into dynamic arrays thatspecifically address the cancer of this particular patient. In otherwords, all of the elements 52 are wired together in series with phase Aand phase B, available for dynamically reassigning any arrayconfiguration to either phase A or B. The deployment of TTF's usingdynamic reassignment of array elements solves many treatment issues,especially for those with metastatic disease. The dynamic assignmentallows for, among other scenarios, a planar treatment regime to be usedfor some of the electrode elements 52, then those same elements can bereassigned to establish a field from one side of the body to the other.

FIGS. 18 to 23 show a TTF treatment sequence using dynamic reassignmentof array elements 52. This particular sequence uses a 6-step firingsequence taking place within a three second time span (0.5 seconds perfiring). Electromagnetic arrays will be formed to treat the liver, lungand upper peritoneal cavity through the abdomen (using parallel arrays).Arrays will be formed to treat the lower peritoneal cavity withhalf-moon fields (coplanar arrays). Some elements will be used multipletimes for different arrays and some will be used for both the A and Bphases. Solid black indicates the A phase and solid gray indicates the Bphase. FIG. 18 begins the treatment sequence with Step 1, treating theliver. FIG. 19 shows Step 2, treating the left lung front to back. FIG.20 shows Step 3, treating the upper peritoneal cavity. Note, many of thesame elements 52 used to form the electromagnetic array for the upperperitoneal cavity where used in the left lung and liver arrays less than1.5 seconds ago. Dynamic reassignment allows this type of enhancedtreatment for the patient. FIG. 21 shows Step 4, treating the lowerperitoneal cavity with a horizontal coplanar field. FIG. 22 shows Step5, treating the lower and upper peritoneal cavity with a verticalcoplanar field. It is well known in TTF research that targeting solidtumors from different angles increases the effectiveness of treatment.As previously stated, the prior art would not allow the treatment Step 5to be included because prior art elements have typically been dedicatedto single arrays and only one power side. The above sequenceincorporates elements 52 that were used in different arrays and powersides less than 1.5 seconds ago. FIG. 23 shows Step 6, treating thelower peritoneal cavity with a diagonal field through the abdomen.

The above process sequence can now be repeated or modified to target theleft lung, liver and peritoneal cavity from many different angles. Thisis possible because of the dynamic reassignment of array elements 52 toany array configuration and either power side. The prior art does nothave this kind of flexibility. The prior art runs into limitationsbecause each element it uses is dedicated to a single array and singlepower side.

Referring now to FIG. 24, there is shown a custom modular system 130using multilayer flex connectors 132. The multilayer flex connectors 132make a modular system for adding and removing array elements 52 possiblebecause they are able to pass heavier currents as well as lowcommunication signals. The multilayer flex connectors 132 via respectivemale and female connectors 134A, 134B interconnect end-to-end elementmodules 136. Thus, these plugin element modules 136 can be added orsubtracted at will. FIG. 24 shows a four-element module 136; however,the number of elements 52 joined end-to-end can be varied according tothe present invention.

As shown in FIG. 25, to deal with current leakage, there is included aplurality of current monitoring sensors 140 that send a shut off signalto the control device 56 if significant current fluctuation is detected.The current monitoring sensors 140 include a communication lead (notshown), and they are located on each element 52. According to thepresent invention, the current monitoring sensors 140 may be hardwiredand/or communicate wirelessly. The current monitoring sensors 140 mayalso be placed at key junctures instead of on each element 52. Thepresent invention can stop using a specific electrode element 52 if thecurrent sensed by sensor 140 exceeds a predetermined amount. The presentinvention will then plan a modified regime to accomplish treatment ofthe patient using the remaining electrode elements 52, so that thetreatments can be completed even if specific electrode elements 52 aretaken off line.

Referring now to FIG. 26, there is shown a method and an embodiment forreducing the temperature and slipping of the array elements 52. Theelectronics of the insulated electrode elements 52 are encapsulated in athermal conductive epoxy 152 with a mushroom shaped male extensions 154.The array elements 52 are attached to the patient's skin using a medicaladhesive (not shown). Then a light, but tight elastic apparel article,in the form of a shirt 156, is pulled over the entire insulatedelectrode array. The plurality of mushroom shaped extensions 154protrude outward from the elements 52 with the elastic shirt 156 tightlywrapped around. A conductive cap 158 is then snapped over the shirt 156and the mushroom male extensions 154 for each element 52. The thermalconductive caps 158 conduct heat and help hold the electrode elements 52in a more stationary position.

Referring now to FIG. 27, there is shown an insulated electrode array170 having large single elements 172 that are also made to bedynamically re-assignable. The insulated electrode array 170 furtherincludes the multilayer flex circuit 54, integrated circuits 60, relays62A and 62B, feedthrough wires, and additionally the current monitoringsensor 140 may be included. In this embodiment there are two largeelectrode elements 172; however, additional large elements 172 and/orsmall elements 52 can also be incorporated. While arrays made up ofsmaller insulated electrodes, elements 52, are generally preferred indelivering TTF treatment, for reasons discussed above, large solidinsulated electrodes with dynamic reassignment may also be useful in aparticular treatment method.

The process for determining a firing configuration and sequence foradministering TTFs when using dynamic reassignment centers upon arrayoptimization in both body composition and treatment area. Placing aninsulated electrode array on a patient's body is a unique process foreach individual patient. Given an individual's body composition, auniform application of the array elements 52 is rarely possible.

The present TTF treatment invention of dynamic reassignment of arrayelements 52 opens the door for full-body treatment with canvassing wavesor other custom configurations. This is most beneficial and lifesavingto patients with metastatic disease, such as breast cancer that hasspread to a patient's lung, pleura, liver, and pancreas at the sametime. However, full-body arrays needed to deliver such treatment seldomfit on a person's body in a uniform way. The irregular nature of eachperson's body due to body shape, bone structure or adiposity requiresplacing array elements 52 at compensating angles. These angles must becompensated for with special field designs (e.g., coplanar fields).Administering TTF using the present invention's dynamic reassignment notonly can accommodate irregular body shapes more affectively, but it canalso do full-body sweeps throughout a patient to minimize the likelihoodof reoccurring cancer.

Referring now to FIG. 28, there is shown an example of an unevenapplication of a TTF insulated electrode array 180 to accommodate aperson's irregular body shape. The insulated electrode array 180 uses acoplanar Phase A and Phase B, respectively 182A and 182B, to create aspecial coplanar field firing sequence through a patient's fat rolls.Also, there is shown the general shape of a vertical coplanar field 184that would be created by the insulated electrode array 180.

In understanding of the embodiments of the present invention it shouldbe appreciated that dynamic reassignments of array elements can beaccomplished by assigning rows or columns of array elements 52. This canbe carried out by strategically placing microprocessors and relay pairsso that they are associated with rows and/or columns instead of beingassociated with every disc element 52. In some configurations thisapproach may reduce cost of the array.

It is also contemplated that a programmable attenuator can be placed inseries with the relay pairs on each array element 52 to thereby allowthe power level of each array element 52 to be adjusted as needed. Thisis a useful feature when sharing array elements across different bodywidths. For example, a programmed side array meant to create a fieldfrom one side of the body to the other (the widest part of the torso inmost patients) may share an array element on its edge with a programmedarray to create a field over the liver from front to back. The powerrequirement to create a field with enough volts per centimeter to beeffective may be more in the side-to-side field than in thefront-to-back field. The adjustable power feature allows an adjustmentof the power in a dynamic fashion to better treat tumors needing thesetypes of custom TTF requirements.

The phenomenon of creating special field designs to compensate bodyshape angles calls for a unique process of fitting a person for TTFtreatment using dynamic reassignment. The flow chart in FIG. 29 outlinesthe unique and extra capabilities of TTF treatment using the presentinvention's method 200 of dynamic reassignment of array elements to anyarray phase A or B.

At step 202 the electrode array of one of the present invention isplaced on the patient making adjustments for irregular body shapes. Atstep 204, the field firing design is optimized to areas most affected bycancer. The shape of the desired field is suggested by the shape,location, and spread of the cancer cells. The optimization leads toselected power levels, selection of electrodes to serve in a dynamicarray, a duration of the assignment of the electrode, frequency of thesignal, duration of the signal, and repetition of the signal among otherpossible variants.

At step 206, the field design is adjusted to accommodate irregular bodyshapes, such as fat rolls. This results in an optimized field coverageof the cancer areas. The firing sequence is undertaken in step 208focused on the most active cancer areas and is continued for aprescribed duration so that the reproduction of cancer cells isinterfered with by the presence of the effective electromagnetic fields.Then at step 210, a broader firing sequence focused on fringe areas isundertaken. Due to the dynamic reassignment capability of the presentinvention steps 208 and 210 may be interleaved, repeated multiple timesper treatment, or done sequentially. After treatment the effectivenessis evaluated at step 212, to provide insight as to how to alter thecharacteristics of the fields for a subsequent treatment. A decision atstep 214 is undertaken to conclude whether the treatment of the patientneeds to continue and if so the next treatment may start at step 202 ifthe electrode array is removed, or at step 204 if the electrode array isleft on the patient.

Use of the term “array” herein has taken different meanings, dependentupon context. In one sense when talking about the grouping of electrodeson the body it is broadly referring to the physical rows and columns ofthe electrodes, or at least their placement, whether in rows and columnsor not. The arrays that are used in forming electromagnetic fields aredynamically selected so that the desired field can be generated and thismeans a subset of the electrodes that may or may not be adjacent areselected and used.

While this invention has been described with respect to at least oneembodiment, the present invention can be further modified within thespirit and scope of this disclosure. This application is thereforeintended to cover any variations, uses, or adaptations of the inventionusing its general principles. Further, this application is intended tocover such departures from the present disclosure as come within knownor customary practice in the art to which this invention pertains and isclaimed in the claims.

What is claimed is:
 1. An insulated electrode system for delivering aplurality of tumor treating electromagnetic fields, comprising: an arrayof electrode elements for proximate location on a body of a patient, thearray is selectively divided into a first sub-array operating as a phaseA of the array and a second sub-array operating as a phase B of thearray, each of said electrode elements having an insulation layer, eachsaid electrode element being independently electrically accessible,programmable and assignable to one of said first sub-array and to saidsecond sub-array to emanate an electromagnetic field relative to atleast one other of said electrode elements assigned to the other one ofsaid first sub-array and said second sub-array, and wherein at least oneof said electrode elements is assignable to both said first sub-arrayand said second sub-array such that said at least one of said electrodeelements is operable as a phase A electrode then as a phase B electrode,a number of phase A electrodes being different than a number of phase Belectrodes.
 2. The insulated electrode system of claim 1, wherein eachof said plurality of electrode elements include: a first LED light; anda second LED light, said first LED light being configured to illuminatewhen the electrode element is assigned to the first sub-array, saidsecond LED light being configured to illuminate when the electrodeelement is assigned to the second sub-array.
 3. The insulated electrodesystem of claim 1, wherein said electrode elements each include: a firstactivatable switch; a second activatable switch; and an integratedcircuit, having a unique address, in communication with said firstactivatable switch and said second activatable switch, the integratedcircuit in communication with the control device, the control devicecarrying out an assignment of each of said electrode elements fordelivering the tumor treating electromagnetic fields.
 4. The insulatedelectrode system of claim 3, wherein said first activatable switch andsaid second activatable switch are in communication with each other byway of a feedthrough wire.
 5. The insulated electrode system of claim 4,further comprising: a field generator for generating the electromagneticfield that is directed to the first sub-array and to the secondsub-array; and a wireless signal generator configured to send a signalto select a set of said electrode elements.
 6. The insulated electrodesystem of claim 5, wherein each said electrode element further includesan antenna and a wireless communication interface coupled with saidintegrated circuit for receiving a command signal from said wirelesssignal generator.
 7. The insulated electrode system of claim 1, whereinsaid plurality of electrode elements each include a microprocessor incommunication with a first activatable switch and a second activatableswitch for assignment of each of said plurality of electrode elementswhen administering tumor treating electric fields, wherein each saidmicroprocessor is programmed for stipulating a firing configuration andsequence that is preloaded in each said microprocessor by the controldevice.
 8. The insulated electrode system of claim 1, further comprisinga master current sensor electrically positioned upstream of saidplurality of electrode elements, said master current sensor beingconfigured to monitor the system for a power fluctuation and to triggera shutting off of the array.
 9. The insulated electrode system of claim1, further comprising a plurality of current monitoring sensors, eachsaid current monitoring sensor being configured to sending a shut offsignal to said control device if a predetermined current fluctuation isdetected in at least one electrode element, wherein each of said currentmonitoring sensors is positioned on a corresponding one of saidplurality of electrode elements.
 10. The insulated electrode system ofclaim 9, wherein said control device is configured to stop using said atleast one electrode element for which said shut off signal has beenreceived.
 11. The insulated electrode system of claim 1, wherein saidplurality of electrode elements each include a separating area orinsulation between two electrically conductive sections each beingassigned to one of the first sub-array and the second sub-array.
 12. Amethod of using an electrode array to deliver tumor treating electricfields to a patient comprising the steps of: arranging an insulatedelectrode element array on the patient; programming a frequency range, afiring configuration and a firing sequence for each of said electrodeelements wherein the electromagnetic elements are arranged to emanateelectromagnetic fields that are configured to treat tumors; assigning atleast some of said electrode elements to a first sub-array operating asa phase A of the electrode element array and at least one of saidelectrode elements to a second sub-array operation as a phase B of theelectrode element array; and assigning at least one of said electrodeelements of said first sub-array operating as a phase A electrode tosaid second sub-array to operate as a phase B electrode, and at leastone of said electrode elements of said second sub-array operating as aphase B electrode to said first sub-array to operate as a phase Aelectrode, wherein a number of phase A electrodes is different than anumber of phase B electrodes.
 13. The method of claim 12, furthercomprising the steps of: adjusting said insulated electrode array on thepatient with adjustments for body composition; and biasingelectromagnetic fields to have a higher firing frequency in areas mostaffected by the cancer by using a plurality of electromagnetic fieldshapes.
 14. The method of claim 13, wherein each of said electrodeelements include: a first LED light; and a second LED light, said firstLED light being configured to illuminate when the electrode element isassigned to the first sub-array, said second LED light being configuredto illuminate when the electrode element is assigned to the secondsub-array.
 15. The method of claim 13, wherein said electrode elementseach include: a first activatable switch; a second activatable switch;and an integrated circuit, having a unique address, in communicationwith said first activatable switch and said second activatable switch,the integrated circuit in communication with the control device, thecontrol device carrying out an assignment of each of said electrodeelements for delivering the tumor treating electromagnetic fields. 16.The method of claim 15, wherein said first activatable switch and saidsecond activatable switch are in communication with each other by way ofa feedthrough wire.
 17. The method of claim 13, wherein said electrodeelements each include a microprocessor in communication with a firstactivatable switch and a second activatable switch for assignment ofeach of said plurality of electrode elements when administering tumortreating electric fields, wherein each said microprocessor is programmedfor stipulating a firing configuration and sequence that is preloaded ineach said microprocessor by the control device.
 18. The method of claim13, further comprising the step of positioning a master current sensorelectrically upstream of said electrode elements, said master currentsensor being configured to monitor the system for a power fluctuationand to trigger a shutting off of the array.
 19. The method of claim 13,further comprising the step of sending a shut off signal to a controldevice from a plurality of current monitoring sensors, each of thecurrent monitoring sensors being configured to send the shut off signalif a predetermined current fluctuation is detected in at least one ofthe electrode elements, wherein a corresponding one of the currentmonitoring sensors is electrically coupled to one of the electrodeelements.